MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Inclusion Criteria:

• Non-hospitalized ambulatory patients with diabetes mellitus

• Men or Women greater than 18 years old

• Patients must be considered reliable, willing and able to give consent

• Female patients must be postmenopausal for a least 6 months or surgically sterilized

• Localized infection of the ulcer that would ordinarily be treated on an outpatientbasis

• Patients who have been previously treated or are currently under treatment for alocalized infections of an ulcer may be enrolled in there has been an adequateresponse to treatment and ulcer is still infected

• Patient must have radiograph within two weeks of entry showing no evidence of corticaldestruction consistent with osteomyelitis

• Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affectedfoot

• Patient may not be taking or have received any other investigational therapy orapproved therapy within 30 days prior to entry

Exclusion Criteria:

• Patients requiring concurrent local or systemic antimicrobials during the study periodfor other infections

• Patients who are currently treated or awaiting dialysis

• Patients who are unable to care for their ulcers

• Patients with known alcohol or substance abuse within 6 months or study entry

• Patients with significant GI problems or surgery that might interfere with theabsorption of ofloxacin

• Patients who are currently receiving systemic corticosteroids, immunosuppressives,antivirals, radiation therapy or cytotoxic agents

• Patients who currently require treatment or a primary or metastatic malignancy or havesystemically immunocompromising disease.

• Previous enrollment in this study or previous treatment with MSI-78 Topical Cream

• Patients with gangrene or severely impaired arterial supply to any portion of theaffected foot

• Other conditions considered by the investigator to be sound reason fordisqualification

• Patients with any known allergy to ofloxacin, other quinolone antibiotics, magaininpeptides or ingredients of the vehicle cream

• Women who are breast feeding, pregnant or attempting to become pregnant